Fujirebio Europe NV
Fujirebio Europe NV
Easy and early plasma pTau181 detection with the LUMIPULSE G platform as indicator of Alzheimer's disease.
An Alzheimer’s Disease (AD) diagnosis is both time-consuming and challenging to obtain. Accumulation of amyloid and tau protein in the brain, the hallmarks of AD, is identified through the use of imaging, including amyloid or Tau PET, or analysis of cerebrospinal fluid (CSF) biomarkers. PET imaging, the only currently FDA approved diagnostic, is not readily available and often prohibitively expensive. Although the amyloid and tau biomarkers (Aβ1-42, Aβ1-40, pTau 181 and total Tau) are well characterized in CSF, these biomarkers are often not utilized due to patient and clinician fears associated with lumbar puncture. Plasma biomarkers for tau offer a minimally invasive tool to identify and monitor individuals suffering from AD or a related dementia. To date, pTau 181 in plasma holds great promise as a biomarker highly specific for AD. Clinical development and validation of this marker in a neurologically diverse population is needed to allow clinical implementation and commercialization of a plasma pTau 181 test. Corresponding CSF and PET data are required to ensure plasma pTau 181 measurements are accurate and also correlate with PET, the current gold standard for AD diagnosis. Commercialization of an easy to run and fully automated Lumipulse G pTau 181 plasma assay will allow simple and rapid identification of individuals with AD facilitating in more efficient drug trial enrollment and development as well as providing answers to millions of individuals suffering from dementia.